TRITTICO 150 mg N20 tab.

Pharmacodynamics

Trazodone, being a triazolopyridine derivative, has a predominantly antidepressant effect, with some sedative and anxiolytic effects. Trazodone has no effect on MAO, which distinguishes it from MAO inhibitors and tricyclic antidepressants.

Quickly affects mental (affective tension, irritability, fear, insomnia) and somatic symptoms of anxiety (palpitations, headache, muscle pain, frequent urination, sweating, hyperventilation).

Trazodone is effective for sleep disorders in patients with depression, increases the depth and duration of sleep, and restores its physiological structure and quality.

Trazodone stabilizes the emotional state, improves mood, reduces pathological craving for alcohol in patients suffering from chronic alcoholism during the period of alcohol withdrawal syndrome, also in remission. For withdrawal symptoms in patients suffering from dependence on benzodiazepine derivatives, trazodone is effective in the treatment of anxiety, depression and sleep disorders. During remission, benzodiazepines can be completely replaced by trazodone.

The drug is not addictive.

Helps restore libido and potency, both in patients with depression and in people who do not suffer from depression.

The mechanism of action of trazodone is associated with the high affinity of the drug for certain subtypes of serotonin receptors, with which trazodone enters into an antagonistic or agonistic interaction depending on the subtype, as well as with the specific ability to cause inhibition of serotonin reuptake.

The neutral uptake of norepinephrine and dopamine has little effect.

The drug does not affect body weight.

Trittico

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

The drug should be prescribed with caution to patients with liver failure.

Use for renal impairment

The drug should be prescribed with caution to patients with renal failure.

Use in children

The use of the drug in children and adolescents under 18 years of age is contraindicated (the safety of trazodone for children has not been established).

Use in elderly patients

For elderly and debilitated patients, the initial dose is up to 100 mg/day in fractional doses or 1 time/day before bedtime. The dose may be increased under medical supervision, depending on the effectiveness and tolerability of the drug. Usually no dose exceeding 300 mg/day is required.

special instructions

People with depression have an increased risk of suicidal thoughts, self-harm, or suicide. The risk may last until significant remission occurs. Since improvement may not occur for the first few weeks of treatment or more, patients should be closely monitored until such improvement occurs. It is common clinical experience that the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before treatment, have a higher risk of suicidal ideation or suicide attempts, and should be closely monitored during treatment. The results of a meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders showed an increased risk of suicidal behavior in patients under the age of 24 years while taking antidepressants compared with placebo. Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or thoughts, or unusual changes in behavior, and to immediately seek professional advice if such symptoms occur.

When treated with trazodone in patients with bipolar disorder, depressive episodes can range from manic-depressive to manic psychosis. In these cases, it is necessary to interrupt treatment.

If you have epilepsy, use trazodone with caution, in particular avoiding sudden increases or decreases in dose.

With simultaneous use of trazodone with drugs that have serotonergic activity (tricyclic antidepressants, selective serotonin reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors and MAO inhibitors) and antipsychotics, serotonin syndrome may occur.

When trazodone is used simultaneously with drugs containing St. John's wort, side effects may be more frequent.

When using trazodone, agranulocytosis may develop, so it is recommended to conduct peripheral blood tests, especially if there is a sore throat when swallowing and fever.

Trazodone is effective for sleep disorders in patients with depression, increases the depth and duration of sleep, and restores its physiological structure and quality.

The use of the drug does not affect body weight.

The drug is not addictive.

Impact on the ability to drive vehicles and operate machinery

During the period of use of the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Pharmacokinetics

Absorption of the drug from the gastrointestinal tract after oral administration is high. Taking trazodone during or immediately after a meal slows the rate of absorption, reduces Cmax of the drug in blood plasma and increases Tmax. Tmax of the drug is achieved 1/2–2 hours after oral administration.

The drug penetrates histohematic barriers, as well as into tissues and fluids (bile, saliva, breast milk).

Plasma protein binding is 89–95%.

Trazodone is metabolized in the liver, the active metabolite is 1-m-chlorophenylpiperazine. T1/2 in the first phase is 3-6 hours, in the second phase - 5-9 hours. The majority of the metabolized drug is excreted through the kidneys, in the urine (about 75%) and is completely completed 98 hours after taking the drug, excreted in the bile about 20%.

In vitro studies on human microsomes have shown that trazodone is primarily metabolized by cytochrome P450 CYP3A4.

Indications for the drug Trittico

anxiety-depressive states of endogenous nature (including involutional depression);

psychogenic depression (including reactive and neurotic depression);

anxiety-depressive states against the background of organic diseases of the central nervous system (dementia, Alzheimer's disease, cerebral atherosclerosis);

depressive states with prolonged pain syndrome;

alcoholic depression;

benzodiazepine dependence;

libido and potency disorders (including erectile dysfunction in depressive conditions).

Contraindications

hypersensitivity to the drug;

pregnancy period;

lactation period;

children under 6 years of age.

The drug should be prescribed with caution to patients with AV block, myocardial infarction (early recovery period), arterial hypertension (dose adjustment of antihypertensive drugs may be required), ventricular arrhythmia, a history of priapism, renal and/or liver failure. Patients under the age of 18 years, due to the possibility of developing the risk of suicidal behavior (suicidal plans, aggressiveness, tendency to contradict, anger).

Side effects

From the side of the central nervous system: increased fatigue, drowsiness, agitation, headache, dizziness, weakness, myalgia, incoordination, paresthesia, disorientation, tremor.

From the cardiovascular system and hematopoietic system: decreased blood pressure, orthostatic hypotension caused by adrenolytic action (especially in persons with vasomotor lability), arrhythmia, conduction disturbances, bradycardia; leukopenia and neutropenia (usually minor)..

From the gastrointestinal tract: dryness and bitterness in the mouth, nausea, vomiting, diarrhea, loss of appetite.

Other: allergic reactions, eye irritation, priapism (you should immediately stop taking the drug and consult a doctor).

Interaction

Trazodone may enhance the effect of some antihypertensive drugs and usually requires a dose reduction.

Simultaneous administration with drugs that depress the central nervous system (including clonidine, methyldopa) enhances the effect of the latter.

Antihistamines and drugs with anticholinergic activity enhance the anticholinergic effect of trazodone.

Trazodone enhances and prolongs the sedative and anticholinergic effects of tricyclic antidepressants, haloperidol, loxapine, maprotiline, phenothiazine, pimozidane and thioxanthine.

When tricyclic antidepressants and trazodone are prescribed simultaneously, cardiovascular side effects may occur.

MAO inhibitors increase the risk of side effects.

When used together, it increases the concentration of digoxin and phenytoin in the blood plasma.

In vitro drug metabolism studies indicate the potential for pharmacological interaction of trazodone with cytochrome P450 CYP3A4 inhibitors such as ketoconazole, ritonavir, indinavir and fluoxetine. Inhibitors of CYP3A4 may lead to significant increases in plasma concentrations of trazodone, thereby increasing the likelihood of adverse events. Therefore, when used in combination with potent CYP3A4 inhibitors, the dose of trazodone should be reduced.

When trazodone is taken in combination with carbamazepine, the plasma concentration of trazodone is reduced. Therefore, patients taking trazodone and carbamazepine concomitantly should be closely monitored.

Trittico 150 mg 20 pcs. tablets aziende chimiche riunite angelini france

pharmachologic effect

Antidepressant.

Composition and release form Trittiko 150 mg 20 pcs. tablets aziende chimiche riunite angelini france

Tablets - 1 tablet:

Active ingredient: trazodone hydrochloride 150.0 mg;
Excipients: sucrose 84.0 mg; carnauba wax 24.0 mg; povidone 24.0 mg; magnesium stearate 6.0 mg.

10 tablets in a PVC/aluminum foil blister.

2 or 6 blisters along with instructions for use in a cardboard box.

Description of the dosage form

Biconvex tablets, white or white with a yellowish tint, oval in color with two parallel lines on both sides.

Characteristic

Triazolopyridine derivative.

Directions for use and doses

Tablets should be taken orally 30 minutes before meals or 2 to 4 hours after meals. The tablets should be taken whole, without chewing, and with plenty of water.

Initial dose of the drug: 100 mg, taken once before bed after meals. On the 4th day you can increase the dose to 150 mg. Further increases in the dose in order to achieve the optimal therapeutic effect should be made by 50 mg/day every 3-4 days until the optimal dose is reached. A daily dose of more than 150 mg should be divided into 2 doses, with the smaller dose taken after lunch and the main dose before bed.

The maximum daily dose for outpatients is 450 mg.

Maximum daily dose for inpatients. 600 mg.

For elderly and debilitated patients, the initial dose is up to 100 mg/day in divided doses or once before bedtime. It can be increased under medical supervision, depending on the effectiveness and tolerability of the drug. A dose exceeding 300 mg/day is usually not required.

Pharmacodynamics

Pharmacodynamics: trazodone inhibits neuronal reuptake of serotonin, is an antagonist of 5-HT2A/2c-serotonin receptors and an α1-adrenergic receptor blocker and has an antidepressant effect.

Pharmacokinetics

Absorption of trazodone from the gastrointestinal tract after oral administration is high. Taking trazodone during or immediately after a meal slows the rate of absorption, reduces the maximum plasma concentration of trazodone, and increases the time to reach maximum concentration (TCmax).

TCmax is achieved 1/2-2 hours after oral administration.

Trazodone penetrates through histohematic barriers into tissues and fluids (bile, saliva, breast milk).

Communication with plasma proteins is 89 - 95%.

Trazodone is metabolized in the liver, the active metabolite is 1-m-chlorophenylpiperazine. The half-life is 3-6 hours, in the second phase 5-9 hours. Elimination of most of the metabolized trazodone is carried out by the kidneys with urine - about 75%, and is completely completed 98 hours after administration; About 20% is administered with bile. In vitro studies on human microsomes have shown that trazodone is primarily metabolized by the cytochrome P450 isoenzyme (CYP3A4 isoenzyme).

Indications for use Trittico 150 mg 20 pcs. tablets aziende chimiche riunite angelini france

Depression with or without anxiety.

Contraindications

Hypersensitivity to the active substance or any excipient;
pregnancy period;
lactation period;
alcohol intoxication and intoxication with sleeping pills;
The safety of trazodone for children under 18 years of age has not been established, therefore the use of the drug in children and adolescents is not recommended;
sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, since the drug contains sucrose.

With caution: the drug should be prescribed with caution to patients with AV block, myocardial infarction (early recovery period), arterial hypertension (dose adjustment of antihypertensive drugs may be required), ventricular arrhythmia, a history of priapism, and renal and/or liver failure.

Application of Trittico 150 mg 20 pcs. tablets aziende chimiche riunite angelini france during pregnancy and breastfeeding

The drug is not recommended for use by pregnant women. The drug is not recommended for use during breastfeeding.

special instructions

Suicide/suicidal ideation or worsening clinical symptoms: Depressive conditions have an increased risk of suicidal ideation, self-harm, or suicide. The risk may last until significant remission occurs. Since improvement may not occur for the first few weeks of treatment or more, patients should be closely monitored until such improvement occurs. It is common clinical experience that the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before treatment, have a higher risk of suicidal ideation or suicide attempts, and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders showed an increased risk of suicidal behavior in patients under 24 years of age when taking antidepressants compared with placebo. Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or thoughts, or unusual changes in behavior, and to immediately seek professional advice if such symptoms occur.

Since the drug has some adrenergic blocking activity, bradycardia and a decrease in blood pressure may develop. Therefore, caution should be exercised when prescribing the drug to patients with a tendency to prolong the QT interval, atrioventricular block of varying severity, and patients with a recent myocardial infarction. When treated with trazodone in patients with bipolar disorder, depressive episodes can range from manic depression to manic psychosis. In these cases, it is necessary to interrupt treatment.

If you have epilepsy, use trazodone with caution, in particular avoiding sudden increases or decreases in dose. With simultaneous use of trazodone with drugs with serotonergic activity (tricyclic antidepressants, selective serotonin reuptake inhibitors, norepinephrine and serotonin reuptake inhibitors and monoamine oxidase inhibitors) and antipsychotics, serotonin syndrome may occur. When trazodone is used simultaneously with drugs containing St. John's wort, side effects may be more frequent.

When using trazodone, agranulocytosis may develop, so it is recommended to conduct peripheral blood tests, especially if there is a sore throat when swallowing and fever.

Trazodone is effective for sleep disorders in patients with depression, increases the depth and duration of sleep, and restores its physiological structure and quality. The use of the drug does not affect body weight.

The drug is not addictive.

Impact on the ability to drive vehicles and operate machinery

During the period of use of the drug Tritgiko, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: drowsiness, dizziness, nausea, vomiting. In more severe cases, coma, tachycardia, hypotension, hyponatremia, seizures and respiratory failure. Impaired function of the cardiovascular system (prolongation of the QT interval, bradycardia). After an overdose, symptoms may take 24 hours or more to appear.

Treatment: There is no specific antidote for trazodone. In cases of overdose, gastric lavage and administration of activated charcoal are necessary within 1 hour after taking the overdose. Symptomatic and supportive treatment is carried out.

Side effects Trittico 150 mg 20 pcs. tablets aziende chimiche riunite angelini france

Trittico may cause side effects, although not all patients experience them.

From the blood and lymphatic system: agranulocytosis, thrombocytopenia, eosinophilia, leukopenia and anemia.

From the immune system: allergic reactions.

From the endocrine system: syndrome of inappropriate secretion of antidiuretic hormone (SNA ADH).

Mental disorders: suicidal thoughts or behavior, confusion, mania, phobias, emotional instability, delirium, hallucinations.

From the nervous system: epileptic seizures, dizziness, headache, insomnia or drowsiness, amnesia, tremor, convulsions, paresthesia, impaired taste.

From the cardiovascular system: palpitations, tachycardia, bradycardia, ventricular extrasystoles, ventricular paroxysmal tachycardia, prolongation of the QT interval, increased blood pressure (BP), decreased blood pressure, fainting.

From the gastrointestinal tract: nausea, vomiting, dry mouth, dyspepsia; abdominal pain, diarrhea, increased salivation, paralytic ileus.

From the skin and subcutaneous tissues: itching, erythematous rash, sweating.

Musculoskeletal and connective tissue disorders: myalgia, arthralgia.

From the kidneys and urinary tract: urinary disorders.

On the part of the genital organs and breast: priapism (patients who experience this side effect should immediately stop taking the drug and consult a doctor).

Other: increased fatigue, weakness, increased body temperature, flu-like syndrome.

Drug interactions

Trazodone may enhance the effect of some antihypertensive drugs and usually requires a dose reduction.

Simultaneous use with drugs that depress the central nervous system (including clonidine, methyldopa) enhances the effect of the latter.

H1-histamine receptor blockers and drugs with m-anticholinergic activity enhance the m-anticholinergic effect of trazodone.

Trazodone enhances and prolongs the sedative and m-anticholinergic effects of tricyclic antidepressants, haloperidol, loxapine, maprotiline, phenothiazine, pimozidan and thioxanthine.

With the simultaneous use of tricyclic antidepressants and trazodone, cardiovascular side effects may occur.

MAO inhibitors increase the risk of side effects.

When used together, it increases the concentration of digoxin and phenytoin in the blood plasma.

In vitro drug metabolism studies indicate the possibility of pharmacological interaction of trazodone with inhibitors of the cytochrome P450 isoenzyme (CYP3A4 isoenzyme), such as ketoconazole, ritonavir, indinavir and fluoxetine. Inhibitors of the CYP3A4 isoenzyme may lead to a significant increase in plasma concentrations of trazodone, thereby increasing the likelihood of adverse events. Therefore, when taken in combination with potent inhibitors of the CYP3A4 isoenzyme, the dose of trazodone should be reduced. When trazodone is taken in combination with carbamazepine, the plasma concentration of trazodone is reduced. Therefore, patients taking trazodone and carbamazepine concomitantly should be closely monitored.

Directions for use and doses

Orally, 30 minutes before or 2–4 hours after meals. The tablets should be taken whole, without chewing and with plenty of water.

The initial dose is 50–100 mg, once before bedtime. On the 4th day it is possible to increase the dose to 150 mg. Further increases in dosage should be made by 50 mg/day every 3–4 days until the optimal dose is reached. A daily dose of more than 150 mg should be divided into 2 doses, with the smaller dose taken after lunch and the main dose before bed.

The maximum daily dose for outpatients is 450 mg, for inpatients - 600 mg.

Children 6–18 years old: initial daily dose of 1.5–2 mg/kg/day, divided into several doses. If necessary, the dose is gradually (with an interval of 3-4 days) increased to 6 mg/kg/day.

Elderly and debilitated patients: initial dose up to 100 mg/day in several doses or once before bedtime. If necessary, the dose can be increased (usually no more than 300 mg/day).

Treatment of libido disorders: recommended daily dose of 50 mg.

Treatment of erectile dysfunction: monotherapy - recommended daily dose - 150-200 mg, combination therapy - 50 mg.

Treatment of benzodiazepine dependence: The recommended treatment regimen is based on a gradual, sometimes over several months, reduction of the benzodiazepine dose. Each time, reducing the benzodiazepine dose by 1/4 or 1/2 tablet, 50 mg of trazodone is added at the same time. This ratio is left unchanged for 3 weeks, then a further gradual reduction in the dose of benzodiazepines is started until their complete withdrawal. After this, reduce the daily dose of trazodone by 50 mg every 3 weeks.

Trittico tab 150mg N20 (Aziende Quimique Riunite Angelini Francesco)

Use in children and adolescents (up to 18 years of age). Trazodone should not be used in children and adolescents under 18 years of age. Suicide/suicidal ideation or worsening clinical symptoms Depressive conditions have an increased risk of suicidal ideation, self-harm, or suicide. This risk persists until significant remission occurs. Since improvement may not occur for the first few weeks of treatment or more, patients should be closely monitored until improvement occurs. It is common clinical experience that the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before treatment, have a higher risk of suicidal ideation or suicide attempts, and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders showed an increased risk of suicidal behavior in patients under 25 years of age with antidepressants compared with placebo. Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or thoughts, or unusual changes in behavior, and to immediately seek professional advice if such symptoms occur. To minimize the potential risk of suicide attempts, especially at the beginning of treatment, the minimum required dose should be prescribed in each specific case. If jaundice develops, trazodone therapy should be discontinued. The use of antidepressants in patients with schizophrenia or other mental disorders may result in possible worsening of psychiatric symptoms. Paranoid thoughts may get worse. When treated with trazodone, depressive episodes can range from manic depression to manic psychosis. In this case, trazodone should be discontinued. Interactions with the development of serotonin syndrome or neuroleptic malignant syndrome. Fatal neuroleptic malignant syndrome has been reported in cases of concomitant use with antipsychotics for which this syndrome was a known possible adverse drug reaction. Since agranulocytosis can manifest itself as a flu-like syndrome, sore throat and fever, it is recommended to monitor the blood count when these symptoms appear. Cases of hypotension, including orthostatic hypotension and syncope, have been reported in patients receiving trazodone. Concomitant use with antihypertensive drugs may require a reduction in the dose of the antihypertensive drug. Elderly patients. Elderly patients are often more responsive to antidepressants, and orthostatic hypotension, somnolence, and other anticholinergic effects of trazodone are more commonly reported. Particular attention should be paid to potential additive effects due to concomitant use of other psychotropic or antihypertensive drugs or in the presence of risk factors, such as concomitant diseases, that may exacerbate these reactions. It is recommended that the patient or caregiver be informed of the possible occurrence of such effects. It is necessary to carefully monitor their manifestation in the patient after initiation of therapy, before and after titration in an increasing dose. During long-term therapy with trazodone, a gradual dose reduction is recommended before discontinuation of the drug to minimize withdrawal symptoms such as nausea, headache, and malaise. There is no evidence that trazodone hydrochloride has any addictive properties. As with other antidepressants, QT prolongation has been reported very rarely with trazodone. Caution should be exercised when administering trazodone with drugs that prolong the QT interval. Trazodone should be used with caution in patients with known cardiovascular disease, including QT prolongation. Strong CYP3A4 inhibitors may result in increased serum levels of trazodone. As with other drugs with alpha-adrenolytic activity, trazodone is very rarely associated with priapism. This can be corrected by intracavernosal injection of an alpha-adrenergic agent such as epinephrine or metaraminol. However, there are reports of trazodone-induced priapism that required surgery or resulted in permanent sexual dysfunction. Patients who develop this suspected adverse reaction should stop taking trazodone immediately. Effect on urine test results. When immunoassays are used to monitor drugs in urine, the reactivity of the trazodone metabolite meta-chlorophenylpiperazine (m-CPP), which is structurally similar to methylenedioxymethamphetamine (MDMA, ecstasy), may cause a false-positive reaction to amphetamine. In these cases, confirmatory analysis using mass spectrometry is recommended.

special instructions

Since the drug has some adrenolytic activity, bradycardia and a decrease in blood pressure may develop. Therefore, caution should be exercised when prescribing the drug to patients with cardiac conduction disorders, AV block of varying severity, or recent myocardial infarction. When using trazodone, a slight decrease in the number of leukocytes is possible, which does not require specific treatment, except in cases of severe leukopenia. Therefore, it is recommended to conduct peripheral blood tests, especially if there is a sore throat when swallowing and fever.

The drug does not have an anticholinergic effect, so it can be prescribed to elderly patients suffering from prostatic hypertrophy, angle-closure glaucoma, and cognitive impairment.

If you experience prolonged and inadequate erections, you should consult a doctor.

There have been no relevant studies on the effectiveness of the drug in pediatrics, so the drug should be used with caution in persons under 18 years of age. Doses for children under 6 years of age have not been established.

During treatment you should refrain from drinking alcohol.

Influence on the ability to drive vehicles and machinery. Since the drug has anxiolytic and sedative activity, a decrease in attention and reaction speed is possible. During treatment, you should refrain from engaging in potentially hazardous activities that require concentration and rapid psychomotor reactions.

Trittico

Suicide/suicidal thoughts or worsening clinical symptoms:

People with depression have an increased risk of suicidal thoughts, self-harm, or suicide. The risk may last until significant remission occurs. Since improvement may not occur for the first few weeks of treatment or more, patients should be closely monitored until such improvement occurs. It is common clinical experience that the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before treatment, have a higher risk of suicidal ideation or suicide attempts, and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders showed an increased risk of suicidal behavior in patients under 24 years of age when taking antidepressants compared with placebo. Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes. Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or thoughts, or unusual changes in behavior, and to immediately seek professional advice if such symptoms occur.

When using trazodone, agranulocytosis may develop, so it is recommended to conduct peripheral blood tests, especially if there is a sore throat when swallowing and fever.

The drug is not addictive.